Allergan Principal Scientist, Analytical Testing & Stability in Irvine, California
Principal Scientist, Analytical Testing & Stability
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/234/other-jobs-matching/location-only
Aug 14, 2016Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
The Principal Scientist is responsible for providing analytical expertise and leadership in the development of drug substances and pharmaceutical products from early development through commercialization. The Principal Scientist will be an instrumental contributor and will be functionally aligned to Small Molecule Product Development. Using advanced analytical technologies, the Principal Scientist will design, manage, lead, and implement analytical development activities in a cGMP environment to support all stages of drug development including drug substance and drug product development.
Main Areas of Responsibilities
Provide oversight to analytical aspects of outsourced programs to ensure the work is performed according to Allergan’s technical standards and expectations.
Interact and negotiate with CRO’s/CMO’s and coordinate to define the analytical deliverables.
Manage CRO/CMO’s activities and ensure the timely generation and reporting of deliverables for assigned CMC project teams.
Provide subject matter expert (SME) technical expertise to CRO’s/CMO’s to support the development of small molecule pharmaceutical products and resolve technical issues.
Actively participate with and provide technical support to CRO’s/CMO’s for OOS/OOT investigations.
Design and direct experiments to solve technical problems that require analytical expertise or data.
Direct laboratory testing at CROs as required to ensure that all data are accurate and reliable, and are generated in an accurate and timely manner and meet all Allergan requirements and that of appropriate regulatory agencies.
Review and approve of CRO and internally generated protocols, reports and data as the technical SME for assigned CMC project teams and coordinate with the quality representative as needed for compliance review.
Prepare appropriate analytical portions of CMC sections of INDs, NDAs, and provide well written responses to questions from world-wide regulatory groups and ministries of health leading to the approval of new drug products.
Actively participate on R&D project teams, as analytical lead, and provide technical support to development projects.
Work with Analytical Director to develop strategic guidance and/or directives to support development and commercialization of product.
Coordinate with the process and product development representatives from various CMC teams to ensure analytical development needs are met (internal or external support), and to establish appropriate control strategy.
Provide written and oral presentations as required to assure adequate communication with various client and management groups.
The following listed requirements need to be met at a minimum level to be considered for the job:
6 years of related pharmaceutical industry experience working in a cGMP analytical laboratory and experience with oversight of drug substance and drug product stability studies to support drug development and product registrations.
Expert hands-on knowledge of advanced chromatographic theory and technology.
Strong working knowledge of HPLC, GC, dissolution, LC-MS, GC-MS, UV/Vis, FTIR and other common analytical techniques used to determine the potency, purity, and in-vitro performance of drug substance/products.
Strong ability to evaluate and interpret analytical results (including stability data) leading to recommendations regarding product quality
Ability to troubleshoot experimental problems and lead investigations to resolve analytical issues.
Knowledge and use of statistics (i.e., hypothesis testing, regression analysis, analysis of variance) for data evaluation.
Knowledge of and familiarity with cGMP and global regulatory requirements for drug substance and drug product stability (FDA and international).
Proven oral communications and technical writing skills, as well as project management skills.
This position may require minimal travel.
The below skills are attributes that may not be mandatory, but are definitely desired in the ideal candidate.
- Experience in authoring relevant CMC sections of regulatory filings.
PhD (or equivalent experience) in Pharmaceutics, Analytical Chemistry, Pharmaceutical Chemistry or Organic Chemistry.